28 REMEDY REPAIR 30G- dimethicone cream 
NoTS Co.,Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1.0%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Melia Azadirachta Extract, Glycerin, Stearyl Alcohol, Niacinamide, Beeswax, Ceresin, Hydrogenated Polyisobutene, Beta-Glucan, PEG-100 Stearate, Glyceryl Stearate, Betaine, Cetyl Ethylhexanoate, Emu Oil, Colloidal Sulfur, Polysorbate 60, Cetearyl Alcohol, Sorbitan Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Butyrospermum Parkii (Shea) Butter, Ethyl Hexanediol, Tromethamine, Carbomer, Tocopheryl Acetate, Cetearyl Glucoside, Glyceryl Caprylate, Disodium EDTA, Salicylic Acid, 1,2-Hexanediol, Adenosine, Hyaluronic Acid, Butylene Glycol, Sophora Angustifolia Root Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Ethylhexylglycerin, Centella Asiatica Extract, Rosa Centifolia Flower Water, Human Oligopeptide-1, Opuntia Ficus-Indica Callus Culture Extract, Salix Alba (Willow) Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Origanum Vulgare Leaf Extract, Cinnamomum Cassia Bark Extract, Scutellaria Baicalensis Root Extract, Chamaecyparis Obtusa Leaf Extract, Propylene Glycol, Allium Sativum (Garlic) Bulb Extract, Brassica Oleracea Italica (Broccoli) Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Spinacia Oleracea (Spinach) Leaf Extract, Arnica Montana Flower Extract, Zinc Oxide, Anthemis Nobilis Flower Extract, Salicornia Herbacea Extract, Vitis Vinifera (Grape) Fruit Extract, Propagermanium, Juglans Regia (Walnut) Seed Extract, Camellia Sinensis Leaf Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Avena Sativa (Oat) Meal Extract

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

Stop use and ask dermatologist or doctor if

•signs of redness, skin swelling, itchy spots, irritation or rash and other appear

•the above signs appear in the applied area by direct rays of the sun

Do not use over

•wounds rashes inflammations other troubled areas.

When using

•Avoid the eye area

•must close the cap after using

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN:

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses Moisturizing and Protecting skin

Directions

Directions:

•Wash your face and dry

•Dispense appropriate amount on your hand

•Apply over your face using your fingers

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

28 REMEDY REPAIR 30G 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69716-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.3 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69716-110-0130 g in 1 CARTON; Type 0: Not a Combination Product01/02/201612/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/201612/01/2018
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(69716-110)

Revised: 12/2018
 
NoTS Co.,Ltd